BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL NECK SLEEVE

    MDR report key: 2223113 · Received August 25, 2011

    Report

    Report Number
    1043534-2011-00483
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 19, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LZO
    PMA / PMN Number
    K072656
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATES THAT PRODUCT MET SPECIFICATION WHEN MANUFACTURED. THE PRODUCT WAS NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Additional Manufacturer Narrative · 1

    DEVICE #4: INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00480, 00481, 00482.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) TOTAL NECK SLEEVE HIP COMPONENT LZO WRIGHT MEDICAL TECHNOLOGY, INC. 03847176010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R